Device recall
Z-0692-2025: Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number…
FDA device recall · Class II · CooperSurgical, Inc.
Key facts
| Recall number (Z-number) | Z-0692-2025 |
|---|---|
| Recall event | 95741 |
| Product | Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos)… |
| Product code | PUB |
| Recalling firm | CooperSurgical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1216677 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database